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New treatment option for Cigarette Smoking Behavior
Official title Effect of Flavored on!® Nicotine Pouch Products on Smoking Behaviors: a SMART Study
ClinicalTrials.gov ID: NCT06072547
What this study is testing
- What it's testing
- The goal of this clinical trial is to learn about the role of flavored on!® nicotine pouch products (the research products), an oral tobacco-leaf-free product, in the replacement of cigarettes with the use of the research products among adults who smoke cigarettes. The main question it aims to answer is whether flavored (vs.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 22 to 65. Healthy volunteers may be eligible.
You may be able to join if
- Has signed the Informed Consent Form (ICF) and is able to read and understand the information provided in the ICF.
- Healthy adults who smoke cigarettes and are 22 to 65 years of age (inclusive) at screening.
- Smokes an average of at least 5 cigarettes per day for the last 12 months.
- Does not intend to use an FDA-approved treatment for nicotine dependence within the next 60 days (as assessed at screening).
- Interested in replacing combustible cigarettes with a smoke-free tobacco product.
You likely can't join if
- Participant enrollment numbers met (in sub-group or entire study).
- Participant, or their first-degree relative (e.g., parent, sibling, child, spouse) or household member, is a current or former employee of the...
- Participant, or their first-degree relative (e.g., parent, sibling, child, spouse) or household member is a named party or class representative in...
- Participant, or their first-degree relative (e.g., parent, sibling, child, spouse), or household member, is a current or former employee of a...
- Participant self-reports being "in poor health."
- Participants of childbearing potential (CBP) who have a positive pregnancy test (as assessed at screening) or are nursing or planning to become...
See the full eligibility criteria
- Has signed the Informed Consent Form (ICF) and is able to read and understand the information provided in the ICF.
- Healthy adults who smoke cigarettes and are 22 to 65 years of age (inclusive) at screening.
- Smokes an average of at least 5 cigarettes per day for the last 12 months.
- Does not intend to use an FDA-approved treatment for nicotine dependence within the next 60 days (as assessed at screening).
- Interested in replacing combustible cigarettes with a smoke-free tobacco product.
- Willing and able to comply with the requirements of the study.
- Owns a smart phone with text message and data capabilities compatible with necessary surveys.
- Participant enrollment numbers met (in sub-group or entire study).
- Participant, or their first-degree relative (e.g., parent, sibling, child, spouse) or household member, is a current or former employee of the tobacco or e-vapor industry.
- Participant, or their first-degree relative (e.g., parent, sibling, child, spouse) or household member is a named party or class representative in litigation involving a tobacco or e-vapor company.
- Participant, or their first-degree relative (e.g., parent, sibling, child, spouse), or household member, is a current or former employee of a marketing consultant, market research firm, advertising or promotions agency...
- Participant self-reports being "in poor health."
- Participants of childbearing potential (CBP) who have a positive pregnancy test (as assessed at screening) or are nursing or planning to become pregnant during their participation.
- Participant has an allergy/sensitivity to menthol or menthol-containing products or phenylalanine.
- Participant has any other self-reported health restrictions.
- Participant self-reports cardiovascular disease, cancer, diabetes, or is being treated for high blood pressure.
- Participant self-reports periodontal disease, gum disease or bleeding, open mouth sores or ulcers.
- Participant self-reports as wanting to stop using tobacco products in the next 60 days.
- Participant has participated in one tobacco research study in the past 30 days OR a tobacco research study lasting two weeks or longer in the past 90 days.
- Participant is unable to read, speak or understand English.
- Participants who ever used at least a pack of nicotine pouch products or currently uses nicotine pouch products.
- Participant who smokes marijuana more than once a week.
- Heterosexually active participants of CBP (not sterilized by tubal ligation, oophorectomy, hysterectomy, or other surgical methods, or post-menopausal) that do not agree to practice medically appropriate methods of...
- Taking psychoactive medications (e.g., antipsychotics or mood stabilizers).
- Cannot participate in the study for any reason (e.g., medical, psychiatric, and or social reason) as judged by the Investigator or designated medical staff based on all available information from the screening period.
The study team makes the final eligibility decision.
Where it's taking place
- Raleigh, North Carolina, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 22 years to 65 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Raleigh, North Carolina, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.